MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 5F TL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000410
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reew4191 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc placed (b)(6) 2020 1 cm external ref ck000410a, this is a 5 french triple lumen powerpicc solo provena picc lot reew4191.(b)(6) 2020 no blood return and coil found in brachial area.Rethreaded in ir on the 29th and next xray on (b)(6) 2021 showed no loop.No product available for return.".
Event or Problem Description
It was reported "picc placed 12/26 1 cm external ref (b)(4), this is a 5 french triple lumen powerpicc solo provena picc lot reew4191.12/28 no blood return and coil found in brachial area.Rethreaded in ir on the 29th and next xray on 1/1/21 showed no loop.No product available for return.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact caused remains unknown.One radiographic image of a catheter within a patient was provided for evaluation.The catheter appears to form a loop within the patient.The event description indicates the catheter is a 5 fr tl powerpicc solo catheter and is looped in the brachial area.Based on the description of the reported event, possible contributing factors include insertion method, securement of catheter, and excessive manipulation of the catheter during use.Since the radiographic image appears to show evidence of a looped and kinked catheter, the complaint is confirmed but the exact cause remains unknown.The report of no blood return was most likely associated with the kinking/coiling of the catheter.H3 : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO2 5F TL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11379773
• Report Number: 3006260740-2021-00489
• Device Sequence Number: 4040847
• Product Code: LJS
• UDI-Device Identifier: 00801741096297
• UDI-Public: (01)00801741096297
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CK000410
• Device Catalogue Number: CK000410
• Device Lot Number: REEW4191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other